Posted on 12/06/2009 in Medical Company Product News Medtronic has announced it plans to commercialise the Bryan Cervical Disc through a controlled market release, which will begin next month.
In July 2007, the company received approval from the Food and Drug Administration for the Prestige device - which was the first of its kind to be permitted.
Now, the regulatory body has given the business the go-ahead to market the new item as a treatment for single-level cervical disc disease.
The Bryan device is a titanium-polyurethane prosthetic item, which is designed to be inserted between the vertebrae as a replacement to a spinal disc.
An alternative treatment, anterior cervical discectomy and fusion (ACDF), does not maintain the range of motion in the neck, which Medtronic's device does.
Dr John Heller is a professor of orthopaedic surgery at Emory University, Atlanta, and commented on investigations of the item.
"At the two-year follow-up in the study, Bryan Cervical Disc patients had statistically superior outcomes in overall success and neck disability index success compared to ACDF patients," he noted.
Last month, Medtronic released data that showed its CoreValve system to be safe and effective.Other news stories from 12/06/2009
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